Daval International Limited Announces Positive Phase II Results for AIMSPRO(R) as a Monotherapy in Established Diffuse Cutaneous Systemic Sclerosis (Scleroderma)

Daval International today announced positive results from its Double-Blind Placebo-Controlled Phase II Clinical Study evaluating the safety and tolerability of AIMSPRO given as a monotherapy to patients with Late Stage Established Diffuse Cutaneous Systemic Sclerosis (diffuse scleroderma). The study evaluated the effects of 4.5mg/ml doses of AIMSPRO, administered subcutaneously, twice weekly for 26 weeks compared with placebo.

The primary endpoint of the study was to evaluate the safety and tolerability of AIMSPRO in the treatment of twenty patients with Systemic Sclerosis (diffuse scleroderma) through a period of 26 weeks of study participation. The secondary outcome measures of the study were to assess the efficacy of AIMSPRO as a therapeutic agent for scleroderma using inter alia the Scleroderma Health Assessment Questionnaire, the Modified Rodnan Skin Score, the Scleroderma UK Functional Score, the Patient and Physician Global Assessment (VAS), the SF-36 (Short form 36) and the MRC Sum Score.

Significantly, at the end of the 26 week period AIMSPRO proved it was a safe and well-tolerated medication when administered to these especially sick patients at such a late-stage of the disease. There was no deterioration in haematological, biochemical, immunologic, cardiologic or in pulmonary parameters that were measured. In addition to the positive safety result, there were encouraging signals of clinical benefit in the secondary outcome measures. The results for the Modified Rodnan Skin Score, a validated measure of disease severity, recorded a worsening in the patients receiving placebo (changes: -27.07%, p=0.29) whereas stability was noted on the patients on AIMSPRO treatment. Furthermore, there was a distinct improvement in the overall SF-36 scores (changes: +41.6%, p=0.184) for the patients receiving AIMSPRO.

There were also trends towards benefit for lung function measures. The Forced Expiratory Volume in one second (FEV1) decreased in the placebo group as compared to baseline at 26 weeks (change: -5.6%; p=0.0582) with no such deterioration being observed in the AIMSPRO treated group. Similarly, the Forced Vital Capacity (FVC) was observed to decrease in the placebo group as compared to baseline at 26 weeks (change: -5.6%, p=0.1038), but not in the AIMSPRO treated group, where the FVC showed an increase (change:+1.8%, p=0.3225).

"Although requiring further confirmatory studies, these results are quite exciting, especially when compared to what has been seen in other pilot trials in scleroderma as there is a clear unmet medical need for patients suffering with this life-threatening disease" said Professor Christopher Denton, Professor of Experimental Rheumatology at the Royal Free Hospital in London, United Kingdom, the principal investigator for the trial. "The important value of the safety data from such a well-conducted trial in such a serious disease is clear, apart from the signals of therapeutic benefit."

Daval's Clinical and Scientific Director, Professor Syed Haq commented, "This study, conducted at one of the world's leading scleroderma centres, was an important first step towards understanding whether AIMSPRO could significantly help patients with diffuse scleroderma and potential overlapping connective tissue disorders, for which there is no cure, by arresting the disease even in its latter stages. AIMSPRO has been shown to be well-tolerated and safe and with the several positive therapeutic signals demonstrated, some of which were significant, it certainly warrants further investigation on a larger scale to determine the full efficacy of AIMSPRO in Late Stage Established Diffuse Cutaneous Systemic Sclerosis."

At the completion of the 26 week period of the study, AIMSPRO was offered to the patients on a compassionate use basis and the results from the 52 week visit will be presented as an addendum to the initial study report.

Daval is now assessing the biomarker data collected in this clinical trial and correlating this with the changes observed, so as to shed more light into the mechanism of action of AIMSPRO in the context of Late Stage Established Diffuse Cutaneous Systemic Sclerosis .

About the Study

This double-blind, randomised, placebo-controlled Phase 2a study of AIMSPRO enrolled twenty patients who received either AIMSPRO or placebo, 4.5mg/ml subcutaneously, twice weekly for 26 weeks. Standard outcome measures and novel biomarkers were used to investigate safety, efficacy and response to treatment.

AboutAIMSPRO®

AIMSPRO is a new generation treatment which combines the benefits of polyclonal antibody (PAb) technology with polypeptide components (PP). It is a pharmaceutically derived biological product that is manufactured and processed using a unique specification that is patent protected and which is derived from a caprine hyperimmune serum source that has been immunised with an inactivated HIV IIIB viral lysate.

About Scleroderma

Scleroderma is an autoimmune connective tissue disease affecting blood vessels and collagen production. It is more common in women than men. The cause is still largely unknown and although there is no cure, there are some treatments available that slow down or halt disease progression. There are two kinds of scleroderma: systemic sclerosis which affects the internal organs as well as the skin, and localised scleroderma which affects a specific area of skin but not the organs.

About Daval

DAVAL INTERNATIONAL LIMITED is an emerging life sciences company focused on the development and delivery of novel and distinctive treatments for serious unmet medical needs through a combination of innovation, dedication, entrepreneurship, skilled science and partnership. From its inception in 2000, the founder and management team of Daval have had a vision of bringing effective treatments that noticeably improves the quality of life of patients suffering from the most serious debilitating neuro-degenerative, inflammatory and autoimmune diseases and to offer a choice over and above some of the disease modifying treatments available currently.

Daval routinely posts information and latest news, including press releases, which may be important to shareholders, health care professionals and patients in the News & Resources section of the company's web site, http://www.davalinternational.com/. The company encourages all interested parties to consult these sections for more information on Daval and its business.